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Phase 2
Phase 3
Age: 18Years - 80Years
All Genders
ID06470191

A Phase IIIII Study Comparing B007 and Cyclosporine Treatments for Primary Membranous Nephropathy

Led by Shanghai Jiaolian Drug Research and Development Co., Ltd · Updated on 2026-05-05

216

Participants Needed

21

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a drug called B007 compared to cyclosporine in treating adults with primary membranous nephropathy, a kidney condition. This study is a multicenter, randomized, controlled, open-label trial conducted in phases II and III to better understand treatment options for this disease. Participants will be randomly assigned to receive either B007 or cyclosporin capsules. B007 is given by subcutaneous injection on days 1 and 15, while cyclosporin capsules are taken orally at a dose of 3.5 mg per kg of body weight per day. The study will observe participants over about two years to assess remission rates and monitor safety. During the trial, participants will undergo laboratory tests and assessments to track overall, complete, and partial remission rates. Researchers will also monitor any treatment-emergent adverse events or serious side effects. Participants must meet specific kidney function criteria and will be followed closely throughout the study period until its completion in late 2026.

CONDITIONS

Brief Title

A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.

Research Team

M

Minghui Zhao

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